- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494786
Palestinian ParentText for Crisis: A Parenting Chabot in War
ParentText for Crisis: A Randomised Controlled Trial of Chatbot-Delivered Mental Health and Parenting Content For Palestinian Caregivers in Jordan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators are conducting an individually randomised controlled trial (cRCT) with 250 Palestinian participants recruited from Jerash Camp. This research is an evaluation of Palestinian ParentText for Crisis in Jordan, a rule-based chatbot to provide tips to strengthen parental mental health, improve parenting practices, and help parents support children in crisis settings. This randomised controlled trial is conducted through a collaboration with the University of Oxford, Parenting for Lifelong Health (PLH), and Sanadak. ParentText for Crisis content is adapted from PLH and "Hope Groups", which is a mental health and parenting programme originally developed from PLH for war and crisis settings. Hope Groups, delivered either in-person, have demonstrated effectiveness in improving caregiver mental health and parenting practices in crisis settings among Palestinians in Jerash Camp, Jordan. This study aims to evaluate the effectiveness of delivering this mental health and parenting content via 9 chatbot-delivered lessons over WhatsApp to Palestinian families within the same camp (Jerash Camp, Jordan). The RCT includes an intervention arm consisting of individuals who are randomised to join CrisisText immediately (n=125), and a waitlist control arm consisting of individuals who are randomised to join CrisisText (n=125) in a second cohort. This is an individually randomised study, with each individual participant as the unit of randomisation. Randomisation will be deployed using the treatment_assign function in the RCT package in R.
The primary aim is to test the effectiveness of ParentText for Crisis 30-days after enrolment, using an individually randomised controlled trial design. Investigators hypothesise that CrisisText will lead to statistically significant improvements in caregiver mental health and positive parenting practices, and reductions in violence against children.
- Timeline will be as follows:
- Individuals who are randomised to the intervention arm will be invited to join an in-person onboarding session. At this session, participants will be given a trigger word to message to the chatbot's number on WhatsApp. Once participants send this message, CrisisText will guide them through informed consent, followed by a short (8 question) baseline survey. After this, the chatbot will begin delivering the first intervention session. Participants will be encouraged to complete this first session at the in-person event, then complete one addition session every day for the next 8 days.
- After the intervention arm concludes the CrisisText intervention, survey questions will appear again. (This data is for exploratory pre-post comparisons.)
- At +30 days after onboarding, the chatbot will message participants to complete a follow-up survey including the same survey questions. (This +30 days follow-up is considered trial endline.)
- During the week of the +30-day follow-up for the intervention arm, the wait-list control arm will be gathered for an in-person meeting to begin the intervention. At this in-person meeting, participants will complete informed consent and a survey. This data from the control arm will be compared with the intervention arm at their +30 day follow up for the primary trial analysis.
- Therefore, this trial's primary analysis will involve a single timepoint comparison: Estimating differences between the intervention arm at 30-day follow-up and the untreated control arm at this same calendar timepoint. To assess baseline balance in this randomised trial, investigators will compare non-time-varying participant demographic variables (e.g., age, sex, number of children) between arms. If there is imbalance, investigators will control for demographic variables in the trial analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jerash, Jordan
- Jerash Camp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Sanadak, a charity in Jordan, will collaborate with the camp to recruit a list of 250 participants. All N=250 individuals, who indicate interested in participating, will be randomised to the intervention or wait-list control arm.
- Inclusion Criteria:
- Adult (aged >=18)
- Parent or caregiver of >=1 child
- Living in Jerash Camp, Jerash, Jordan (a refugee camp for Palestinians from Gaza)
- Have access to a phone with WhatsApp
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ParentText for Crisis
A rule-based chatbot to provide tips to strengthen parental mental health, improve parenting practices, and help parents support children in crisis settings
|
A rule-based chatbot to provide tips to strengthen parental mental health, improve parenting practices, and help parents support children in crisis settings
|
|
No Intervention: Comparison Group
Wait-List Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Depression
Time Frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Caregiver depression is measured via Patient Health Questionnaire - 2 (PHQ-2).
PHQ-2 includes two questions on depression, with likert scale answer options ranging 0-3.
Higher scores indicate higher levels of depression.
|
Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
|
Playful Parenting
Time Frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Parenting Practices are measured via a positive parenting item adapted from Alabama Parenting Questionnaire, measuring frequency of playing with children in the past week.
Survey responses are reported in days of occurrence within the past week (0-7), with higher scores indicating higher level of playful parenting.
|
Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Hopefulness
Time Frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Caregiver Hopefulness is measured through an item building on positive psychology theory, asking, "How many days in the past week did you feel hopeful about the future?"
Answer options range from 0-7 to reflect days of occurrence in the past week.
Higher scores indicate high levels of hopefulness.
|
Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
|
Parenting Practices
Time Frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Parenting Practices are measured through a parental involvement question adapted from Alabama Parenting Questionnaire and a Parental Supervision question adapted from Alabama Parenting Questionnaire.
Answer options for both questions are reported in days of occurrence in the past week (0-7), with higher scores indicating higher levels of positive parenting practices.
|
Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
|
Violence Against Children
Time Frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Violence Against Children is measured via 2 questions on physical and emotional violence actions from the ISPCAN Child Abuse Screening Tool for Trials (ICAST-Trial).
Questions ask about frequency of occurrence in days in the past week, with answer options range from 0-7.
Higher scores indicate higher frequency of violence against children.
|
Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2256451 Palestinian Evaluation
- https://osf.io/q5s4k/overview (Registry Identifier: Open Science Framework. This is a carbon-copy of an OSF preregistration on December 5, 2025.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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